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Tasigna (Chronic Myeloid Leukemia) - Forecast and Market Analysis to 2022

Published By :

GlobalData

Published Date : May 2013

Category :

Oncology

No. of Pages : 54 Pages


Tasigna (Chronic Myeloid Leukemia) Forecast and Market Analysis to 2022

Summary

GlobalData has released its new PharmaPoint Drug Evaluation report, Tasigna (Chronic Myeloid Leukemia) Forecast and Market Analysis to 2022. Chronic myeloid leukemia (CML) is a rare myeloproliferative blood cancer that is characterized by the presence of the BCR-ABL fusion protein. The stage of CML is classified as chronic, accelerated or blast phase, ranging from least to most severe. Multiple BCR-ABL tyrosine kinase inhibitors (TKIs) are approved, and are the standard of care for CML. TKIs have transformed most cases of the disease into a manageable, chronic condition. As a result, patients survival rates and the prevalence of CML are increasing, placing a growing burden on global healthcare systems.

Novartis Tasigna (nilotinib) is a second-generation BCR-ABL TKI. It was first approved in the US and 5EU in 2007 and in Japan in 2009 as a second-line therapy for patients with CP or AP CML that was intolerant or resistant to Gleevec. Shortly thereafter, in 2010, Tasigna gained regulatory approval for the first-line treatment of CP-CML patients in the US and the EU. In Japan, Tasigna received this brand extension in 2011. It is approved and reimbursed for both indications in all the 7MM. Tasigna has orphan drug designation from both the FDA and the EMA. Tasigna is administered twice daily at a dose of 300mg for newly diagnosed CP CML or 400mg when used as a second-line therapy, and must be taken on an empty stomach.

Scope


  • Overview of CML, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
  • Detailed information on Tasigna including product description, safety and efficacy profiles as well as a SWOT analysis.
  • Sales forecast for Tasigna for the top seven countries from 2012 to 2022.
  • Sales information covered for the US, France, Germany, Italy, Spain, the UK and Japan

Reasons to buy


  • Understand and capitalize by identifying products that are most likely to ensure a robust return
  • Stay ahead of the competition by understanding the changing competitive landscape for CML
  • Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
  • Make more informed business decisions from insightful and in-depth analysis of Tasigna performance
  • Obtain sales forecast for Tasigna from 2012-2022 in top seven countries (the US, France, Germany, Italy, Spain, the UK and Japan)
Table of Contents

1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 7
1.2 List of Figures 7

2 Introduction 8
2.1 Catalyst 8
2.2 Related Reports 8

3 Disease Overview 10
3.1 Etiology and Pathophysiology 10
3.1.1 Etiology 10
3.1.2 Pathophysiology 11
3.1.3 Clinical Staging 13
3.1.4 Prognosis 14
3.1.5 Quality of Life 15
3.2 Symptoms 16

4 Disease Management 17
4.1 Global Trends 17
4.1.1 Treatment Overview 17
4.1.2 Diagnostic Tests 20
4.1.3 Genetic Testing 21
4.1.4 Monitoring Patient Response to Treatment 23
4.1.5 Future Directions: Discontinuation Therapy 26

5 Competitive Assessment 28
5.1 Overview 28
5.2 Strategic Competitor Assessment 29

6 Product Profile - Tasigna (nilotinib) 32
6.1 Overview 32
6.2 Efficacy 34
6.3 Safety 35
6.4 SWOT Analysis 36
6.5 Forecast 37

7 Appendix 38
7.1 Bibliography 38
7.2 Abbreviations 40
7.3 Methodology 43
7.4 Forecasting Methodology 43
7.4.1 Diagnosed CML patients 43
7.4.2 Drug-treated Patients on X Line of Therapy 44
7.4.3 General Pricing Assumptions 44
7.4.4 Compliance Assumptions for Oral TKIs 46
7.4.5 Individual Drug Assumptions 47
7.4.6 Generic Erosion 47
7.4.7 Pricing of New Market Entrants 47
7.5 Physicians and Specialists Included in this Study 48
7.6 Survey of High Prescribing Physicians 49
7.7 About the Authors 50
7.7.1 Authors 50
7.7.2 Epidemiologists 51
7.7.3 Global Director of Epidemiology and Clinical Trials Analysis 52
7.7.4 Global Head of Healthcare 53
7.8 About GlobalData 54
7.9 Contact Us 54
7.10 Disclaimer 54

List of Table


Table 1: The Staging of CML as Defined by Commonly Used Staging Systems 13
Table 2: Prognostic Scoring Systems for CML 14
Table 3: Common Symptoms of CML by Disease Phase 16
Table 4: Most Commonly Followed Treatment Guidelines for CML 19
Table 5: Most Prescribed First-Line Therapies for CP, AP and BP CML in the Global Markets, 2013 19
Table 6: Suggested Treatments for CML Patients with Selected BCR-ABL Kinase Domain Mutations 22
Table 7: CML Response Types, Criteria, and Corresponding Tests 24
Table 8: Leading Treatments for Chronic Myeloid Leukemia, 2013 31
Table 9: Product Profile Tasigna 33
Table 10: Molecular and Cytogenetic Responses of Tasigna Compared with Gleevec in Newly Diagnosed Ph+ CML in CP 34
Table 11: Tasigna SWOT Analysis, 2013 36
Table 12: Global Sales Forecasts ($m) for Tasigna in CML, 20122022 37
Table 13: Physicians Surveyed, by Country 49

List of Chart


Figure 1: Translocation of Chromosomes 9 and 22 10
Figure 2: Comparison of Normal and Leukemia Blood Cells 11

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